This leaflet tells you about oral contraceptives in general and about Norgeston in detail. Please read it carefully to get the best from Norgeston. If you are in any doubt about these instructions contact your doctor, pharmacist or Family Planning clinic.

You can usually become pregnant (conceive) from when you start to have periods, up until you are in your late 40s. Every menstrual cycle takes about 28 days. About halfway through this cycle an egg is released from one of your ovaries into a fallopian tube. This is called ovulation.

The egg travels down the fallopian tube towards your womb. When you make love, your partner's penis releases millions of sperm into your vagina. Some of these sperm travel up through your womb into your fallopian tubes. If there is an egg in one of these tubes, and a sperm reaches it, you can become pregnant. This is called 'conception'.

A fertilised egg gets embedded in the lining of your womb and takes 9 months to grow into a baby. As an egg can live for up to 2 days, and sperm for up to 5 days, you can become pregnant if you have made love up to 5 days before ovulation and for some time afterwards. If a sperm does not fertilise an egg, the egg is lost at the end of the menstrual cycle with the lining of your womb. This is called a 'period'.

Your menstrual cycle is controlled by two sex hormones made by your ovaries: one called oestrogen, the other progesterone (a progestogen). Oestrogen increases during the first half of your menstrual cycle and makes your womb develop a thick lining, ready to receive the egg if conception happens. Progesterone comes later in the cycle and changes the lining of the womb still further to prepare it for pregnancy.

If you do not become pregnant, you make less of these hormones and this causes the lining of your womb to break down and the lining leaves your body as a period. But during pregnancy, your ovaries, and then the placenta (this attaches the growing baby to the womb and gives it food), carry on making progesterone and oestrogen to stop any more eggs being released.

There are two types of pill, the combined pill and the progestogen-only pill. A combined pill contains two hormones which are like those your body produces (oestrogen and progestogen).

Norgeston is a progestogen-only pill which contains only progestogen and no oestrogen.

Norgeston works by thickening the fluid (mucus) in the neck of your womb (cervix) which makes it more difficult for sperm to enter the womb. It also changes the lining of your womb so that it does not thicken enough for an egg to grow in it. In some women it also stops the ovary releasing an egg each month (ovulation).

Progestogen-only pills, such as Norgeston, are not quite as effective as combined oral contraceptives. However, Norgeston provides a very high degree of protection against pregnancy.

To make Norgeston as effective as it can be you must take it regularly, and at the same time each day. You must follow your doctor's instructions and take the tablets exactly as it says in this leaflet.

Norgeston also contains the following inactive ingredients: lactose, maize starch, povidone, polyethylene glycol 6000, calcium carbonate (E170), talc, magnesium stearate (E572), sucrose, montan glycol wax.

Each pack of Norgeston contains a memo strip of 35 tablets.

Norgeston is a progestogen-only contraceptive pill. Progestogen-only contraceptives contain one female type of hormone, a progestogen.

Schering Health Care Ltd

The Brow, Burgess Hill, West Sussex, RH15 9NE

Product licence number 0053/0068

Norgeston is manufactured by: Schering AG, Berlin, Germany.

Norgeston is an oral contraceptive. When used as instructed you are very unlikely to become pregnant.

Before taking Norgeston, tell your doctor if you have any of these:

• you are pregnant or think you may be pregnant.
• blood clots in the legs, lungs, eyes, or anywhere else or have ever had these. If you have had a heart attack or if you have any medical condition which makes you more at risk of developing blood clots.
• abnormal red blood cells (sickle-cell anaemia).
• cancer of the breast (mammary carcinoma) or have ever had this condition.
• abnormal bleeding from your vagina of unknown cause.
• certain types of jaundice (Dubin-Johnson or Rotor syndromes).
• severe diabetes with changes to the blood vessels.
• liver tumours or have ever had these.
• any other long or short-term liver disease.
• allergy to any of the ingredients of Norgeston.

Do not take Norgeston if you have had any of these conditions when you were pregnant:

• itching of your whole body (pruritus of pregnancy).
• the rash known as herpes gestationis.
• yellowing of the skin ( jaundice).

Before you start taking Norgeston your pelvic organs, breasts and blood pressure should be checked by your doctor and these checks should be repeated regularly. The doctor will also make sure you are not pregnant.

Diabetes (diabetes mellitus) or a tendency towards diabetes needs watching carefully while you are taking the pill.

If you have had an ectopic pregnancy (where the foetus develops somewhere other than the womb), or one of your fallopian tubes is missing, you should discuss this with your doctor before using Norgeston.

If you have an irregular menstrual pattern together with stomach pains whilst taking Norgeston, you should see your doctor.

Some medicines may stop Norgeston from working properly. If you are taking any other medicine while you are taking Norgeston, be sure to tell your doctor (or dentist). Your doctor (or dentist) can tell you whether you should use extra contraceptive precautions and for how long.

Medicines which can sometimes stop Norgeston from working properly are antibiotics (such as ampicillin and rifampicin); griseofulvin (which is used to treat fungal infections); phenylbutazone (which is used as an anti -inflammatory drug to treat some types

of joint diseases); phenytoin, primidone, phenobarbitone and some other medicines used in people with epilepsy and carbamazepine (which can be used to treat epilepsy or other illnesses).

If you are taking any of these medicines you might still be able to use Norgeston, but you will also need to use an extra contraceptive method (condoms or cap plus spermicide) while you are taking the other medicine and for 14 days after you stop taking it. If you are taking griseofulvin, phenylbutazone, phenytoin, primidone, phenobarbitone, carbamazepine or other drugs to treat epilepsy for a long time you may not be able to use Norgeston. Check with your doctor, pharmacist, or Family Planning clinic.

If you are taking rifampicin you will need to use another method of contraception as well as Norgeston. You should do this while you are taking the rifampicin and for 4 weeks after you stop.

If you are diabetic your doctor may alter the dose of medicine required to treat your diabetes.

If you are in doubt check with your doctor, pharmacist or Family Planning clinic.

Being sick or having very bad diarrhoea may stop Norgeston from working properly and make it less effective. Carry on taking Norgeston as usual, and also use another method of contraception (condom or cap plus spermicide) until 14 days after you have recovered from the stomach upset. If your stomach upset continues for some time, consult your doctor who may consider another form of contraception.

If you are sick (vomit) very soon after taking your pill you can take another pill within 3 hours of the normal time and you will then have contraceptive protection (as long as you are not sick again). You can use the last pill in the pack for this purpose. If you have repeated vomiting use an extra method of contraception as described above.

It has been suggested, on the basis of statistical evidence that the risk of developing various disorders of the circulation of the blood is slightly greater in women who take the pill than in those who do not. This can lead to, for example, deep vein thrombosis (blood clot in the leg), strokes (blood clots and haemorrhages from the blood vessels of the brain), heart attacks or pulmonary embolism (blood clots blocking the arteries of the lungs). People do not always fully recover from these disorders, and, very rarely they are fatal. However, such associations are less clear with progestogen-only pills.

Certain conditions increase the risk of thrombosis. They include:

• smoking.
• obesity.
• some diseases of the heart and blood vessels.
• diabetes.
• migraine.
• a major operation or period of immobilisation (e.g. you are in bed after an accident or operation or you have a plaster cast on a broken leg).
• if any members of your family have suffered from thromboembolic diseases (e.g. deep vein thrombosis, strike or heart attack) at a young age.
• varicose veins.

If any of these conditions apply to you before you decide to take Norgeston or while you are taking Norgeston you must discuss them with your doctor.

The risk of arterial thrombosis (e.g. heart attack and stroke) associated with the pill increases with age, and this risk is increased by cigarette smoking.

Signs and symptoms of blood clots are given in the section "Reasons for stopping Norgeston immediately".

Therefore, if you have pain in the upper abdomen that does not soon clear up, tell your doctor. Also, if your skin becomes yellow ( jaundice) you must tell your doctor.

If you think you might be pregnant, stop taking Norgeston and consult your doctor immediately. Use another method of contraception such as a condom until you see your doctor.

Certain conditions may sometimes get worse during use of the pill. The diseases are those listed under "What you should know before taking Norgeston".

If you experience any of the following conditions, take no further tablets of Norgeston and consult your doctor immediately. In the meantime use another method of contraception such as a condom.

• migraine for the first time, or if existing migraine occurs more often than before.
• unusually bad headaches or if you have headaches more often than before.
• sudden changes to your eyesight, hearing, speech, sense of smell, taste or touch.
• Unusual pains in your leg or unusual swelling of your arms or legs, sharp pains in your chest or sudden shortness of breath, crushing pains or feelings of heaviness in your chest, coughing for no apparent reason, dizziness or fainting, or if one side of your body suddenly becomes very weak or numb. These may be symptoms of blood clot formation or symptoms of an inflammation of veins combined with the formation of blood clots (thrombophlebitis).
• your skin becomes yellow ( jaundice), you develop hepatitis (inflammation of the liver) or if your whole body starts itching.
• a large increase in your blood pressure.
• definite worsening of conditions which had got worse during a previous pregnancy or while taking the pill in the past.
• pregnancy.
• Surgery or immobilisation. You must stop Norgeston six weeks before a planned major operation (e.g. stomach surgery), if you are having any surgery to the legs, or medical treatment for varicose veins. Also if you are immobilised for a long time (e.g. you are in bed after an accident or operation or you have a plaster cast on a broken leg). Your doctor will advise you when to start taking Norgeston again.

This pack is designed to help you remember to take your pills.

If you are new to the pill or are starting the pill again after a break, take your first Norgeston tablet on the first day of bleeding of your next period. For other users, follow instructions for "Changing from another type of oral contraceptive", "Starting Norgeston after having a baby" or "Starting Norgeston after a miscarriage or an abortion".

Start with a pill marked with the correct day of the week, for instance, if your period starts on a Wednesday, start with a pill marked "Wed".

After taking your first pill, take one pill each day, following the direction of the arrows, until the pack is empty.

You should try to take the pill at the same time every day, for example, after breakfast, so that the interval between tablets is always 24 hours.

Swallow each pill whole, with water if necessary.

When you have finished the first pack, start a new pack the very next day, again taking a pill marked with

that day of the week. For example, if you finish your pack on a Tuesday start the next pack on Wednesday with a pill marked "Wed". Do not leave a gap between packs.

You will be taking pills through your periods and there must be no break between packs.

If you are starting Norgeston immediately after any other oral contraceptive, finish that pack and then start taking Norgeston the next day. Do not leave a gap between packs. Start with a pill marked with the correct day of the week. Then follow the instructions under "Taking your first pack of Norgeston". You should use another method of contraception, such as a condom, for the first 14 days of tablet taking. This is for the first pack only.

If you have just had a baby, your doctor may advise you to start taking Norgeston 7 days after delivery, provided you are fully mobile. You do not have to wait for a period. You will need to use another method of contraception, such as a condom. until you start Norgeston and for the first 14 days of pill taking. Follow the instructions as before (see "Taking your first pack of Norgeston").

Norgeston has not been shown to reduce the amount of milk you produce. There is no evidence to suggest that the small amounts of the hormone that appear in the milk are harmful to a healthy baby. However, if your baby has severe or long-standing jaundice that requires medical treatment you should not breast-feed your baby after being given Norgeston.

If you have just had a miscarriage or an abortion your doctor may advise you to start using Norgeston immediately. You should use another method of contraception, such as a condom, for the first 14 days of tablet taking. This is for the first pack only. Follow the instructions as before (see "Taking your first pack of Norgeston").

Your periods may be irregular, you may have some bleeding between periods, or you may have no periods at all. This is normal when taking Norgeston, especially during the first few months. These changes generally require no treatment. If, however, the bleeding is heavy and last a long time, you should discuss this with your doctor.

What to do if you miss a period

While this can mean you are pregnant, it is most unlikely if you have taken your pills correctly. However, you should see your doctor if you have had no bleeding for 6 weeks.

Each pack of Norgeston contains a calendar. Your doctor may ask you to fill this in. Your doctor will then be able to check your pattern of bleeding.When you start taking Norgeston, fill in the name of the month and put an 'S' (start) in the appropriate date square. As this first day of pill-taking will be on the first day of a period, put an 'X' for this day and all the other days of your period. If you forget to take one or more pills, mark these days with an 'O'.

If you forget to take a pill please follow these instructions:

If you are more than 3 hours late in taking a pill, or have missed one or more pills contraceptive protection may be lower, so you must use extra protection. You must continue taking your pills at your normal time and use an extra contraceptive method (e.g. condoms) for the next 14 days.

Don't worry. Contraceptive protection should not be affected if you take the late pill at once, and keep taking your next pills at the usual time.

Your doctor relies on the date of your last true period before you get pregnant to tell you when your baby will be born. So, if you stop taking Norgeston to have a baby, use another method of contraception until you have had a natural period. However, it will not be harmful if you become pregnant straight away.

If overdose does occur, no serious ill-effects are expected. Contact your doctor or pharmacist if you are at all worried.

Sometimes mild unwanted effects can occur in the first few months after starting Norgeston:

• bleeding and spotting between your periods.
• no periods.
• headaches or migraine.
• feeling sick, being sick and stomach upsets.
• depressive moods, loss of interest in sex.
• dizziness
• allergic reactions.
• changes in weight.

If you think that you have any unwanted effect due to Norgeston, even if it has not been mentioned, or you have a serious reaction as described earlier in this leaflet, tell your doctor or pharmacist.

The use of oral contraceptives may affect the results of certain laboratory tests. Always tell your doctor or the laboratory staff that you are using an oral contraceptive.

Expiry date: The expiry date is printed on the pack. Do not use after this date.

Storage: Store all medicines out of the reach of children.

Date of last revision of this leaflet: 18 January 1996